MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10094910

Device Problem Fire (1245)

Patient Problem Sore Throat (2396)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address:: a customer contact name was provided in japanese characters and was not translated for reporting.The customer facility phone number is +0584813341.Initial corrective actions/preventive actions implemented by the manufacturer: the system was taken out of use at the affected site.With the currently available information no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the cause for the fire has not been identified yet.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.

Event Description

When the room was vacant after an examination the fire alarm in the examination room went off.Smoke and fire were emitted from the system.The fire was extinguished by staff.At first it was communicated that no injury occurred.However, additional information was received stating the radiology technicians involved in extinguishing the fire complained of sore throats.There was no patient involvement.The system was taken out of use.It is currently unclear what the cause for the fire was.The issue is reported because the circumstances are still unclear, and a fire was communicated.In case of a fire a serious injury cannot be excluded.Further information was requested for investigation.

Manufacturer Narrative

The investigation of the reported event started shortly following the incident by the siemens local service organization, the local police and fire departments.It was communicated that on (b)(6) 2023, the police had seized the affected m2 electronic box, where the four motor controllers were mounted.The fire department suspected the motor controller u160 to be the origin of the fire.The uroskop omnia system was dismantled and brought to a local warehouse for further analysis.Circuit diagrams of the controller u160 were provided by the manufacturer lenze to the investigators.The investigation by the local fire department concluded that the fire had caused the most damage to the back side of the resistor r5 of the u160 controller.Upon completion of local investigations by the police and the fire departments, the uroskop omnia system was sent to kemnath, germany, for further investigation.The system was inspected by siemens product and electronic experts from kemnath.All cabling at the input and the output side of the u160, as well as winding of the motor that is connected to the u160 was checked via visual inspection and electrical measurements.Defective cablings and short circuits inside the motor and all other peripherical causes were excluded as reason for the fire.The material testing laboratory reviewed the circuit diagram of the u160 for possible causes of overheating.Optical assessment of the u160 controller confirmed that the resistor r5 was thermally destroyed.The material testing laboratory identified that the origin of the thermal energy that led to the fire in the m2 electronics assembly was the resistor r5.The only available log files are dated one week prior to the incident.No traces of unusual user workflows could be found.The cause for the resistor to overheat is still under investigation.

• Brand Name: UROSKOP OMNIA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17716893
• MDR Text Key: 323035327
• Report Number: 3004977335-2023-00111
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/10/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1